PTSDPRIMED-PTSDNCT04504149
Shared Decision Making for PTSD in Primary Care
A study testing Patient Readiness for Improvement through Motivation, Engagement, and Decision-making for PTSD in people with PTSD, run by VA Office of Research and Development at 1 site in United States.
Trial summary
PTSD is one of the most common mental health conditions affecting Veterans and is associated with significant burden. Highly effective treatments exist for PTSD, evidence-based psychotherapies, but very few Veterans receive them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- Patient Readiness for Improvement through Motivation, Engagement, and Decision-making for PTSD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2022to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult VA patients 18 years who have a documented initial visit to Primary Care-Mental Health Integration for PTSD in the past 90 days at VA Puget Sound
Who cannot join
- Cognitive impairment (e.g., moderate or severe history of traumatic brain injury, dementia)
- Unstable acute psychiatric conditions (e.g., current high-risk for suicide)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
About this study
Official title: Patient Readiness for Improvement Through Motivation, Engagement, and Decision-making for PTSD (CDA 18-186)
PTSD is one of the most common mental health conditions affecting Veterans and is associated with significant burden. Highly effective treatments exist for PTSD, evidence-based psychotherapies, but very few Veterans receive them. Although VA has trained over 8,500 providers in evidence-based psychotherapies for PTSD over the past 10 years, only 6% of the 650,000 VHA patients with PTSD receive an evidence-based psychotherapy. It is critical to connect Veterans with the most effective PTSD treatments and done so in a way that is Veteran-centered. Shared decision making is a patient-centered approach to choosing healthcare treatment options. It has been shown to increase patients' motivation for treatment and ability to stay in treatment long enough to get benefit. It has also been shown to help providers align their practice with evidence-based guidelines. This proposal will refine and pilot test a shared decision making intervention for PTSD to be used in VA primary care clinics, where the vast majority of Veterans with PTSD are treated.
Read the detailed description
Background: Over 1 million Veterans have PTSD and most (80% or more) do not receive first-line treatments, evidence-based psychotherapies, despite significant VA investment to increase access to these treatments. Clinicians often struggle to engage Veterans in evidence-based psychotherapies because they can be emotionally challenging treatments. Engagement could be catalyzed by mental health providers integrated into primary care (i.e., VA's Primary Care-Mental Health Integration, or PC-MHI) to maximize the reach of engagement efforts beyond specialty PTSD settings. Shared decision making, a process by which the patient and provider discuss treatment options, weigh benefits and risks, and select a treatment that meets the patient's needs, addresses known patient and provider barriers to evidence-based psychotherapies, including knowledge, self-efficacy, and trust. However, no study has examined shared decision making for PTSD in primary care. The proposal will address this knowledge gap by developing and refining a shared decision making intervention for PTSD, Patient Readiness for Improvement through Motivation, Engagement, and Decision-making (PRIMED), using input from Veterans with diverse perspectives, PC-MHI providers, and VA operational partners to optimize integration of shared decision making into clinical care. The investigators will collect acceptability and feasibility data to support an application for a future effectiveness-implementation trial.
Significance/Impact: Dr. Chen's proposed research addresses three HSR\&D and VA priorities: 1) increase engagement and retention of Veterans in evidence-based PTSD treatments, 2) advance health services research methods, specifically implementation science and user-centered design, which focuses on thorough integration of Veteran and frontline provider input, and 3) support suicide prevention efforts through effective treatment of PTSD, a major risk factor for suicide.
Innovation: The proposed project will promote significant change in current VA clinical practice. PC-MHI providers typically refer out patients with PTSD and defer discussions about treatment options to specialty providers. This proposal will help PC-MHI providers use a formal engagement strategy, shared decision making, to improve patients' knowledge of first-line PTSD treatments and to build motivation for care.
Specific Aims: 1) Refine PRIMED using user-centered design methods and diverse Veterans' perspectives, 2) Beta test PRIMED in one rural and one urban PC-MHI clinic to optimize integration into clinical workflow and achieve satisfactory acceptability and feasibility across a range of settings, 3) Conduct a small, randomized pilot trial (N=40) of PRIMED vs. usual care in two VA PC-MHI clinics to assess the feasibility of study procedures, which will inform a future larger trial.
Methodology: In Aim 1, Dr. Chen will conduct qualitative interviews using user-centered design methods with 25 VA PC-MHI patients with PTSD, oversampling women veterans and racial/ethnic minority veterans, to refine the PRIMED intervention protocol. In Aim 2, Dr. Chen will use rapid, iterative beta-testing with approximately 20 patients to optimize the acceptability and feasibility of delivering PRIMED in the clinical setting and its integration into clinical workflow across varied settings (small rural clinics and large urban clinics). In Aim 3, Dr. Chen will conduct a pilot randomized feasibility trial (N=40) to assess the feasibility of recruiting and randomizing Veterans and measuring treatment engagement and clinical outcomes.
Next Steps/Implementation: The research and training activities will prepare the nominee to conduct a multi-site, hybrid type 1 effectiveness-implementation trial to test the effectiveness of PRIMED for increasing receipt of first-line PTSD treatments and to begin to assess implementation barriers and facilitators. Future work to move this research into practice would involve collaborating with operational partners to improve VA SAIL performance measures in mental health, which are weighted to encourage evidence-based psychotherapies.
- Conditions
- PTSD
- Being tested
- Patient Readiness for Improvement through Motivation, Engagement, and Decision-making for PTSD
- Keywords
- Primary Care, Decision Making, Shared, Stress Disorders, Post-Traumatic
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Readiness for Improvement through Motivation, Engagement, and Decision-making for PTSDBehavioural
Also called PRIMED
A primary care-based shared decision making intervention
| Study group | Role | What they receive |
|---|---|---|
| PRIMED | Experimental | Shared decision making session Receives: Behavioral: Patient Readiness for Improvement through Motivation, Engagement, and Decision-making for PTSD |
| Usual Care | No intervention | The investigators will characterize usual care using chart review and administrative data to identify medications (prescribed, filled), number of mental health sessions received, types of providers seen, and the content of treatment sessions as captured in chart notes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CollaboRATE
CollaboRATE is a a 3-item instrument developed for measuring patient-centeredness within SDM. Good patient acceptability will be defined as minimum ratings of 3 (some effort was made) on a 0 (no effort was made) to 4 (every effort was made) scale for every one of the 3 questionnaire items: 1) How much effort was made to help you understand your health issues?, 2) How much effort was made to listen to the things that matter most to you about your health issues?, 3) How much effort was made to include what matters most to you in choosing what to do next?
Measured: 2 weeks
Utilization of evidence-based psychotherapies (EBPs) for PTSD
The investigators will use chart review methods to identify utilization of EBPs. One method is as a dichotomous (yes/no) measure of initiation.
Measured: 6 months
Utilization of evidence-based psychotherapies (EBPs) for PTSD
The investigators will measure the number of EBP sessions received in 6 months.
Measured: 6 months
Utilization of evidence-based psychotherapies (EBPs) for PTSD
The investigators will measure time to initiation, defined as days between the initial PC-MHI triage visit and first EBP session.
Measured: 6 months
Secondary outcomes (5)
PTSD Knowledge Questionnaire
Knowledge about PTSD and its treatment will be assessed with a 43-item true-or-false questionnaire, which was used in a previous RCT of a paper-based PTSD decision aid. Items will rated as o (incorrect) or 1 (correct), with a total score ranging from 0-43. Higher scores indicate more accurate knowledge.
Measured: 2 weeks
Decisional Conflict Scale
The DCS is a 16-item scale that assesses patient-reported uncertainty around treatment decision-making. The items also assess the degree to which patients feel informed about risks and benefits, clear about their personal attitudes and values, supported by other(s), and effective in decision making. The items are rated from 0 (strongly agree) to 4 (strongly disagree), with a range from 0 to 64. Higher scores indicate better outcomes, i.e., more confidence and feeling more informed.
Measured: 2 weeks
Perceived Stigma and Barriers to Care for Psychological Problems
The investigators will use a 10-item version adapted for Veterans to assesses perceived barriers to mental health treatment related to access, stigma, and trust in providers. Higher scores indicate worse outcomes, i.e., more perceived stigma and barriers to care.
Measured: 2 weeks
Generalized Self-Efficacy
A 10-item scale that measures an individual's perceived ability to problem solve, follow through with decisions, and cope effectively with challenges. Items are rated from 0 (not at all true) to 4 (exactly true) and summed. Higher scores indicate better outcomes, i.e., greater confidence.
Measured: 2 weeks
Wake Forest Physician Trust Scale
A 10-item scale that measures patients' trust in their care providers. The scale total ranges from 10 to 50. Higher scores indicate more trust. Example questions include "Sometimes your doctor cares more about what is convenient for [him or her] than about your medical needs" and "Your doctor is totally honest in telling you about all of the different treatment options available for your condition." The language will be adapted so that "mental health provider" replaces "doctor" to clearly indicate to patients the relationship of interest.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start3 Oct 2022
- Primary completion16 Nov 2022
- Study completion30 Nov 2022
Why it stopped: Findings from Aims 1 and 2 clarified that any future trial should involve provider- or clinic-level randomization, not patient-level randomization.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patient Readiness for Improvement through Motivation, Engagement, and Decision-making for PTSD, hereafter PRIMED, is a primary care-based shared decision making (SDM) intervention that the investigators will develop using UCD methods for VA Primary Care-Mental Health Integration (PC-MHI) clinics to engage Veterans in first-line treatments for PTSD.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jessica A. Chen, PhD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504149
- Sponsor's protocol ID
- CDX 20-002
- Acronym
- PRIMED-PTSD
- Status last verified
- Dec 2022
- First submitted
- 29 Jul 2020
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Readiness for Improvement Through Motivation, Engagement, and Decision-making for PTSD (CDA 18-186)
- ClinicalTrials.gov ID
- NCT04504149
- Acronym / sponsor ID
- PRIMED-PTSD / CDX 20-002
- Conditions
- PTSD
- Keywords
- Primary Care, Decision Making, Shared, Stress Disorders, Post-Traumatic
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Findings from Aims 1 and 2 clarified that any future trial should involve provider- or clinic-level randomization, not patient-level randomization.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PTSD is one of the most common mental health conditions affecting Veterans and is associated with significant burden. Highly effective treatments exist for PTSD, evidence-based psychotherapies, but very few Veterans receive them. Although VA has trained over 8,500 providers in evidence-based psychotherapies for PTSD over the past 10 years, only 6% of the 650,000 VHA patients with PTSD receive an evidence-based psychotherapy. It is critical to connect Veterans with the most effective PTSD treatments and done so in a way that is Veteran-centered. Shared decision making is a patient-centered approach to choosing healthcare treatment options. It has been shown to increase patients' motivation for treatment and ability to stay in treatment long enough to get benefit. It has also been shown to help providers align their practice with evidence-based guidelines. This proposal will refine and pilot test a shared decision making intervention for PTSD to be used in VA primary care clinics, where the vast majority of Veterans with PTSD are treated.
Detailed description
Background: Over 1 million Veterans have PTSD and most (80% or more) do not receive first-line treatments, evidence-based psychotherapies, despite significant VA investment to increase access to these treatments. Clinicians often struggle to engage Veterans in evidence-based psychotherapies because they can be emotionally challenging treatments. Engagement could be catalyzed by mental health providers integrated into primary care (i.e., VA's Primary Care-Mental Health Integration, or PC-MHI) to maximize the reach of engagement efforts beyond specialty PTSD settings. Shared decision making, a process by which the patient and provider discuss treatment options, weigh benefits and risks, and select a treatment that meets the patient's needs, addresses known patient and provider barriers to evidence-based psychotherapies, including knowledge, self-efficacy, and trust. However, no study has examined shared decision making for PTSD in primary care. The proposal will address this knowledge gap by developing and refining a shared decision making intervention for PTSD, Patient Readiness for Improvement through Motivation, Engagement, and Decision-making (PRIMED), using input from Veterans with diverse perspectives, PC-MHI providers, and VA operational partners to optimize integration of shared decision making into clinical care. The investigators will collect acceptability and feasibility data to support an application for a future effectiveness-implementation trial.
Significance/Impact: Dr. Chen's proposed research addresses three HSR\&D and VA priorities: 1) increase engagement and retention of Veterans in evidence-based PTSD treatments, 2) advance health services research methods, specifically implementation science and user-centered design, which focuses on thorough integration of Veteran and frontline provider input, and 3) support suicide prevention efforts through effective treatment of PTSD, a major risk factor for suicide.
Innovation: The proposed project will promote significant change in current VA clinical practice. PC-MHI providers typically refer out patients with PTSD and defer discussions about treatment options to specialty providers. This proposal will help PC-MHI providers use a formal engagement strategy, shared decision making, to improve patients' knowledge of first-line PTSD treatments and to build motivation for care.
Specific Aims: 1) Refine PRIMED using user-centered design methods and diverse Veterans' perspectives, 2) Beta test PRIMED in one rural and one urban PC-MHI clinic to optimize integration into clinical workflow and achieve satisfactory acceptability and feasibility across a range of settings, 3) Conduct a small, randomized pilot trial (N=40) of PRIMED vs. usual care in two VA PC-MHI clinics to assess the feasibility of study procedures, which will inform a future larger trial.
Methodology: In Aim 1, Dr. Chen will conduct qualitative interviews using user-centered design methods with 25 VA PC-MHI patients with PTSD, oversampling women veterans and racial/ethnic minority veterans, to refine the PRIMED intervention protocol. In Aim 2, Dr. Chen will use rapid, iterative beta-testing with approximately 20 patients to optimize the acceptability and feasibility of delivering PRIMED in the clinical setting and its integration into clinical workflow across varied settings (small rural clinics and large urban clinics). In Aim 3, Dr. Chen will conduct a pilot randomized feasibility trial (N=40) to assess the feasibility of recruiting and randomizing Veterans and measuring treatment engagement and clinical outcomes.
Next Steps/Implementation: The research and training activities will prepare the nominee to conduct a multi-site, hybrid type 1 effectiveness-implementation trial to test the effectiveness of PRIMED for increasing receipt of first-line PTSD treatments and to begin to assess implementation barriers and facilitators. Future work to move this research into practice would involve collaborating with operational partners to improve VA SAIL performance measures in mental health, which are weighted to encourage evidence-based psychotherapies.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patient Readiness for Improvement through Motivation, Engagement, and Decision-making for PTSD, hereafter PRIMED, is a primary care-based shared decision making (SDM) intervention that the investigators will develop using UCD methods for VA Primary Care-Mental Health Integration (PC-MHI) clinics to engage Veterans in first-line treatments for PTSD.
| Arm | Type | Receives |
|---|---|---|
| PRIMED | Experimental | Behavioral: Patient Readiness for Improvement through Motivation, Engagement, and Decision-making for PTSDShared decision making session |
| Usual Care | No intervention | –The investigators will characterize usual care using chart review and administrative data to identify medications (prescribed, filled), number of mental health sessions received, types of providers seen, and the content of treatment sessions as captured in chart notes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult VA patients 18 years who have a documented initial visit to Primary Care-Mental Health Integration for PTSD in the past 90 days at VA Puget Sound
Key exclusion criteria (2 listed)
- Cognitive impairment (e.g., moderate or severe history of traumatic brain injury, dementia)
- Unstable acute psychiatric conditions (e.g., current high-risk for suicide)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Readiness for Improvement through Motivation, Engagement, and Decision-making for PTSDAlso: PRIMEDA primary care-based shared decision making intervention | Behavioural | PRIMED |
Primary outcome
CollaboRATE
Time frame: 2 weeks
CollaboRATE is a a 3-item instrument developed for measuring patient-centeredness within SDM. Good patient acceptability will be defined as minimum ratings of 3 (some effort was made) on a 0 (no effort was made) to 4 (every effort was made) scale for every one of the 3 questionnaire items: 1) How much effort was made to help you understand your health issues?, 2) How much effort was made to listen to the things that matter most to you about your health issues?, 3) How much effort was made to include what matters most to you in choosing what to do next?
Utilization of evidence-based psychotherapies (EBPs) for PTSD
Time frame: 6 months
The investigators will use chart review methods to identify utilization of EBPs. One method is as a dichotomous (yes/no) measure of initiation.
Utilization of evidence-based psychotherapies (EBPs) for PTSD
Time frame: 6 months
The investigators will measure the number of EBP sessions received in 6 months.
Utilization of evidence-based psychotherapies (EBPs) for PTSD
Time frame: 6 months
The investigators will measure time to initiation, defined as days between the initial PC-MHI triage visit and first EBP session.
5 secondary outcomes
PTSD Knowledge Questionnaire
Time frame: 2 weeks
Decisional Conflict Scale
Time frame: 2 weeks
Perceived Stigma and Barriers to Care for Psychological Problems
Time frame: 2 weeks
Generalized Self-Efficacy
Time frame: 2 weeks
Wake Forest Physician Trust Scale
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica A. Chen, PhD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Readiness for Improvement through Motivation, Engagement, and Decision-making for PTSD in people with PTSD, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CollaboRATE (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022; AzTrials last refreshed its copy on 28 Oct 2026.